Survanta 25 mg/mL
Beractant · SUSPENSION · AbbVie Inc.
Survanta is a suspension containing beractant at 25 mg/mL, taken endotracheal. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Survanta
- Generic Name
- Beractant
- NDC Code (Product)
0074-1040- Manufacturer
- AbbVie Inc.
- Strength
- 25 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ENDOTRACHEAL
- Marketing Status
- Application #
- BLA020032
- Drug Class
- Surfactant [EPC]
- Marketing Start
- 07/01/1991
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
Dosage & Administration
DOSAGE AND ADMINISTRATION Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant. Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing. Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter. Recommended Dosage Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). In the prevention strategy, in premature infants with evidence of surfactant deficiency, give the first dose of SURVANTA as soon as possible, preferably within 15 minutes of birth. To treat infants with RDS confirmed by radiographic and clinical findings, give the first dose of SURVANTA as soon as possible, preferably by 8 hours of age. F…
Warnings
WARNINGS SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
Contraindications
CONTRAINDICATIONS None
Adverse Reactions
ADVERSE REACTIONS The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses . Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment. The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3. Table 3. All Controlled Studies Concurrent Event SURVANTA (%) Control (%) P -Value a Patent ductus arteriosus 46.9 47.1 0.814 Intracranial hemorrhage 48.1 45.2 0.241 Severe intracranial hemorrhage 24.1 23.3 0.693 Pulmonary air leaks 10.9 2…
Frequently Asked Questions
What is Survanta used for?
Survanta contains Beractant. It is a suspension taken endotracheal. Consult your doctor for specific uses.
Is Survanta a controlled substance?
Survanta is not classified as a controlled substance by the DEA.
What is the generic name for Survanta?
The generic name for Survanta is Beractant. There are no other listed brand versions of Beractant.
What is the NDC code for Survanta 25 mg/mL?
The NDC (National Drug Code) for Survanta 25 mg/mL is 0074-1040, listed by AbbVie Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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